FDA warns against purchase of unregistered food items including popular liver spread brand

Marje Pelayo   •   September 17, 2020   •   842

MANILA, Philippines — The Food and Drug Administration (FDA) on Wednesday (September 16) issued a warning against the purchase and consumption of several unregistered food and food supplements including a popular brand of liver spread.

According to its advisory dated August 26 and released only on September 16, the following products have no certificate of product registration issued and therefore unregistered in the agency:

  • Reno Brand Liver Spread
  • Miracle White Advance Whitening Capsules Food Supplement
  • Turcumin 100% Natural & Standardized Turmeric Curcumin
  • Desa Spanish Style Bangus In Corn Oil
  • Samantha’s Dips And Sauce Spanish Sardines Paste Sauce

“Since these unregistered food products and food supplements have not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety,” the advisory said.

The FDA cited the provision of the Food and Drug Administration Act of 2009, which states that “the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.”

The agency also warned establishments not to distribute, advertise or sell the said violative food products until a proper certificate of registration is issued.

Otherwise, they could face regulatory sanctions.

COVID-19 vaccine approval in PH possible in April 2021 – FDA

Robie de Guzman   •   September 25, 2020

MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.

During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.

“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.

“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.

In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.

“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.

Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.

“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.

The DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the sharing of their earlier trial results.

Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.

The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)

FDA warns public against purchase, use of ‘misbranded’ face masks

Robie de Guzman   •   August 6, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Thursday warned healthcare professionals and the general public not to purchase and use face masks that are ‘misbranded’ and are sold in foreign characters.

In an advisory posted on Wednesday, the FDA identified the following misbranded face masks labeled in foreign characters:

  • Fu Le Bang disposable mask
  • Flag World Face Mask
  • Mask

The agency said that the mentioned medical device products are being offered for sale in the local market as verified through a post-marketing surveillance.

Republic Act 9711 or the FDA Act states that a device shall be deemed misbranded if any word, statement, or other information required to appear on the label is not appropriately placed or understandable to consumers.

The FDA said the manufacture, importation, exportation, sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any misbranded health products is prohibited under the law.

The agency called on its regional field offices, law enforcement agencies and local government units to ensure that these products are not sold nor made available in the market or their areas of jurisdiction.

The FDA also urged the Bureau of Customs to restrain the entry of these misbranded products in the country.

23 out of 163 potential COVID-19 vaccines under clinical trial—FDA

Aileen Cerrudo   •   July 16, 2020

The Food and Drug Administration (FDA) said 23 out of 163 potential vaccines for coronavirus disease (COVID-19) are currently under clinical testing stage.

According to FDA Director General Eric Domingo, two potential COVID-19 vaccines will be given to a larger group of people to see if it is effective and to further evaluate its safety.

The said vaccines are Astrazeneca, currently being developed in London, and Sinovac that is being developed in China.

Department of Health (DOH) Spokesperson Usec. Maria Rosario Vergeire said that the anti-flu drug Favipiravir or Avigan, from Japan is also nearing clinical trials.

“We are fortunate that the Japanese have reached out to us to help increase the sample size of their Avigan drug trial, a potential treatment to prevent people from dying from COVID-19,” she said.

Meanwhile, the FDA has confirmed that another potential vaccine is being developed in Russia. Domingo said it is currently in the advanced phase.

“Ginagamit na rin siya sa clinical trial ng ibang bansa mayroon din sa Japan, China, United States, Italy at Russia, (It is currently under clinical trial in other countries like Japan, China, United States, and Russia),” he said.

The medicine for Ebola Virus, Remdesivir, is currently under solidarity trial. Remdesivir is being used in other countries to treat severe COVID-19 patients. AAC (with reports from Aiko Miguel)

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